BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 19838983 · Received July 26, 2024

    Report

    Report Number
    3013886523-2024-00217
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 4, 2024
    Report Date
    March 7, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519171
    PMA / PMN Number
    K053107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE VALVE RECEIVED IS A CERTAS VALVE WHILE THE COMPLAINT CONCERNS A CHPV VALVE. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-1745 WITH LOT 7204533, CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE RECEIVED IS NOT THE CORRECT ONE. THE VALVE RECEIVED IS A CERTAS VALVE WHILE THE COMPLAINT CONCERNS A CHPV VALVE. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED BECAUSE THE VALVE RECEIVED IS NOT THE CORRECT ONE. THE VALVE RECEIVED IS A CERTAS VALVE WHILE THE COMPLAINT CONCERNS A CHPV VALVE. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM AND IDENTIFY THE ROOT CAUSE OF THIS ASSUMPTION AS THE GOOD PRODUCT WAS NOT RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823114) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. BUT IT WAS NOT POSSIBLE TO CONFIRM AND IDENTIFY THE ROOT CAUSE OF THIS ASSUMPTION AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED ON (B)(6) 2023. IT STOPPED DRAINING, THEREFORE, THE VALVE WAS REPLACED ON (B)(6) 2024. THE PATIENT IS DOING WELL. ACCORDING TO INFORMATION PROVIDED, IT IS NOT KNOWN IF THERE WAS AN OBSTRUCTION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614471 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 7204533 10381780519171

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Female Required Intervention